Job title: Manager, Regulatory Affairs
Company: Merck Sharp & Dohme
Job description: Job Description
Manager, Regulatory Affairs
THE OPPORTUNITY
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
WHAT WILL YOU DO:
1. NEW PRODUCT REGISTRATION
Develops, drives and finalizes new products approvals in India and for all products in neighboring markets, in line with local regulatory requirements and business plans.
Ensures submission in a timely manner and follow up to obtain earliest approvals for new products approvals in India and for neighboring markets.
During the assessment of the registration files, ensures adequate follow-up with regulatory agencies and addresses quickly agencies’ requests on quality clinical and non-clinical information.
Coordinates actions effectively and proactively with HQ and local support groups and in order to support products launches in due time and avoid business loss.
2. MAINTANENCE OF EXISTING PRODUCTS
Ensures timely submission and follow up of both labeling and quality-related variations to the marketing authorizations, in cooperation with the key stakeholders: Ex., worldwide product labeling, CMC, RAI, HQ and
regional regulatory support team.
Ensures timely submission and follow up of quality-related variations (CMC) to the marketing authorizations, in cooperation with the key stakeholders to the Health Agency laboratory.
Manages renewal process in liaison with CMC, RAI, HQ and regional regulatory support team ensuring that renewal files are prepared, submitted and approved in due time.
Efficient regulatory input for packaging and label components to ensure timely implementation of artwork efforts.
3. REGULATORY COMPLIANCE
Responsible for implementing local regulatory procedures in a timely manner, in close synergy with HQ /regional groups.
Trains appropriate personnel on regulatory procedures.
Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures
4. REGULATORY INTELLIGENCE
- Pro-actively shares intelligence on competitive products, generics, as well as on emerging regulations
- Responsible for supporting competitive intelligence
WHAT YOU MUST HAVE:
Education – Bachelor degree in Biological Sciences – eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
Working knowledge of Indian regulatory mechanism
Detail oriented, meticulous and organized
Basic IT knowledge
Able to work within targeted timelines
Good project management skills
Self-motivated and strong commitment to achieve desired results and right first time
Team player
Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace
Current Employees apply
Current Contingent Workers apply
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation: Domestic/International
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings: 1
Expected salary:
Location: Gurgaon, Haryana
Job date: Fri, 18 Mar 2022 00:01:54 GMT
Apply for the job now!
